Benitec Biopharma Limited announced the selection of the University of California - San Diego (UCSD), Health Sciences as the second site for its upcoming phase I/II first-in-man trial for TT-034 in Hepatitis C infections (HCV). Benitec previously announced the selection of Duke Clinical Research Unit as the other site. TT-034 is being developed as a potential 'one-shot-cure' for HCV. A consultant and sub-principal investigator for the study from UCSD Health Sciences will be Robert Gish, M.D., clinical professor of Medicine and medical director of Hepatology. Dr. Gish is a renowned hepatitis researcher with previous experience using RNAi based therapeutics for HCV. He has over 500 publications in the field and is a fellow of the American College of Physicians and the American Association for the Study of Liver Disease. The principal investigator for the study at UC San Diego is David Wyles, M.D., associate professor of Medicine at the UC San Diego AntiViral Research Center, the clinical research site that will be conducting the trial. His research interests include the laboratory evaluation of new antiviral therapies for HCV, drug resistance to HCV antivirals, and HCV viral fitness. The phase I/II clinical trial is an open-label dose escalation study to evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who have failed previous treatments. The trial is expected to involve 14 patients in 5 sequential dose cohorts. Additional consolidation cohorts may be added during the study to confirm the results of the trial. The primary safety endpoints are dose limiting adverse events. The primary end points are serum viral load reduction and degree of hepatocyte transduction (measured through liver biopsies). There is a pre-specified interim read on safety and activity within months of trial commencement. TT-034 is a potentially transformative therapeutic that is intended to provide a 'one-shot-cure' for Hepatitis C with a single injection. TT-034 works through RNA interference (RNAi), which is a naturally occurring regulatory process in cells that acts to 'silence' genes after they have been transcribed from DNA into messenger RNA. Benitec's proprietary ddRNAi approach involves the introduction of a DNA vector that produces short hairpin RNAs (shRNAs) that are processed by the cell into siRNAs. This approach emulates the cell's own gene silencing mechanism and provides long term activity (months). Moreover, the virus vector used to deliver the TT-034 construct, an engineered non-replicating adeno-associated virus (AAV8), targets almost exclusively liver cells (where HCV replicates). TT-034 is further designed to prevent viral escape through mutations (a major problem for most HCV drugs) by using three different shRNAs to simultaneously target three separate highly conserved regions in the HCV genome. In mice and monkeys, TT0-034 has been shown to transduce 100% of hepatocytes in the liver and provide high shRNA activity for 180 days (the duration of the studies), without adverse effects.

Benitec Biopharma Limited reported that Mr. Kevin Buchi, has accepted an invitation to join the company's Board of Directors. Mr. Buchi currently serves on the Board of Directors of Stemline Therapeutics Inc., Forward Pharma A/S and Alexza Pharmaceuticals Inc.

Benitec Biopharma Limited reported consolidated earnings results for the six months ended December 31, 2012. For the six months, the company reported revenue of AUD 600,534 compared to revenue of AUD 207,770 for the same period a year ago. Loss before income tax was AUD 3,567,277 compared to AUD 2,245,584 last year. Loss was AUD 3,567,277 compared to AUD 2,245,584 last year. Total comprehensive loss attributable to the members of the company was AUD 3,567,277 or AUD 0.36 per basic and diluted share compared to AUD 2,245,584 or 0.24 per basic and diluted share last year. Net cash outflows from operating activities were AUD 1,878,712 compared to AUD 1,750,562 last year. Purchase of plant and equipment was AUD 2,399 compared to AUD 17,836 last year.